A laboratory information management system (LIMS) facilitates sample management and test execution against the specification criteria in a compliant, scientific platform to support GMP Quality and Manufacturing. Vault LIMS connects to Vault Quality and manages the quality control testing of manufactured batches for market release.
Vault LIMS enables seamless information sharing between lab users, delivering real-time data for more informed decision-making. Automated digital workflows improve test efficiency, reliability, and accuracy. Vault LIMS leverages functionality from connected applications, including quality document management and QMS objects.
Vault LIMS Data Model
There are two broad categories of components in the Vault LIMS data model: Design Data components and Run Time components. Design Data includes the Test Definitions, Sample Plans, Lab Study Designs, and Spec Data, including the mapping of the components to particular Materials, Country, and Organization combinations, which allows LIMS to automatically select them upon batch creation. Vault LIMS creates Runtime Data from Spec Data components and facilitates high volume, controlled data capture throughout the QC process, from sample collection to batch release.
Design Data
These objects and their supporting objects form the design from which Vault generates the runtime data records.
Runtime Data
When a user creates a runtime object, such as a Batch or Lab Sample, LIMS automatically selects the relevant Test Definition, Sample Plan, and Spec Data records for the selected Material, Country, and Organization combination and uses this to generate the runtime data records.
LIMS Terminology
When used in LIMS help articles, the following terms refer to specific Vault objects in the LIMS data model:
| Term | Vault Object |
|---|---|
| Test Definition | Lab Test Definition (lims_test_definition__v) |
| Test Definition Step | Lab Test Definition Step (lims_test_definition_step__v) |
| Test Definition Input | Lab Test Definition Input (lims_test_definition_input__v) |
| Test Definition Result | Lab Test Definition Result (lims_test_definition_result__v) |
| Test Definition Result Variable | Lab Test Definition Result Variable (lims_test_definition_result_variable__v) |
| Sample Plan | Lab Sample Plan (lims_sample_plan__v) |
| Sample Definition | Lab Sample Definition (lims_sample_definition__v) |
| Spec Data | Spec Data (lims_spec_data__v) |
| Spec Data Sample Action | Spec Data Sample Action (lims_spec_data_sample_action__v) |
| Spec Data Criteria | Spec Data Criteria (lims_spec_data_criteria__v) |
| Spec Data Criteria Set | Spec Data Criteria Set (lims_spec_data_criteria_set__v) |
| Batch | Batch (quality_batch__v) |
| Spec Execution | Spec Execution (lims_spec_execution__v) |
| Lab Sample | Lab Sample (lims_sample__v) |
| Lab Test | Lab Test (lims_sample_test__v) |
| Lab Test Input | Lab Test Input (lims_test_input__v) |
| Lab Result | Lab Result (lims_result__v) |
| Study Design Overview | Study Design Overview (lims_study_design_overview__v) |
| Study Overview | Study Overview (lims_study_overview__v) |
| Lab Storage Condition | Lab Storage Condition (lims_storage_condition__v) |
| Lab Study Design | Lab Study Design (lims_study_design__v) |
| Lab Study Design Timepoint | Lab Study Design Timepoint (lims_study_design_timepoint__v) |
| Lab Study | Lab Study (lims_study__v) |
| Lab Study Timepoint | Lab Study Timepoint (lims_study_timepoint__v) |
LIMS Help Personas
For the purposes of this Vault LIMS documentation, users are classified into several basic industry standard roles:
Design Data Admin
A Design Data Admin user is responsible for creating and versioning Test Definitions, Spec Data, and Sample Plans.
Lab Analyst
A Lab Analyst user is responsible for executing tests on lab samples and capturing the results.
Lab Manager
A Lab Manager is responsible for managing all the tests that need to be executed for samples received by the lab, and monitoring tests for out of control or out of specification.
Quality Authority
A Quality Authority is responsible for reviewing sample data trending and compliance to specification ranges and procedure requirements.
Vault Admin
The Vault Admin user is responsible for configuring the objects, document types, lifecycles, workflows, and other components of the Vault, to ensure a compliant LIMS implementation.